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临床试验/NCT02588885
NCT02588885已完成不适用

Restoring Emotional, Sexual, and Physical Empowerment Through CBT & Trauma-sensitive Care: A Chronic Pelvic Pain Intervention

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
2
主要终点
Chronic pelvic pain

研究概览

简要总结

This project will develop and preliminarily examine RESPECT, a trauma-sensitive psychological and physical therapy intervention to treat chronic pelvic pain, posttraumatic stress symptoms (PTS), and dysfunctional sexual behavior among women with sexual abuse histories. Patients will be recruited after being referred to pelvic floor physical therapy for treatment of chronic pelvic pain. Participants will complete seven sessions of individual cognitive behavioral psychotherapy. Physical therapy will be provided by clinicians who have been trained in trauma-sensitive treatment techniques. Treatment acceptability and outcomes will be assessed at baseline, mid intervention, post-intervention and follow-up via self-report measures. The RESPECT protocol is expected to be feasible to implement among sexual abuse survivors and to be well liked by patients. RESPECT is expected to reduce chronic pelvic pain, PTS, dysfunctional sexual behavior, treatment avoidance.

详细描述

This project will develop and preliminarily examine RESPECT, a trauma-sensitive psychological and physical therapy intervention to treat chronic pelvic pain, posttraumatic stress symptoms (PTS), and dysfunctional sexual behavior among women with sexual abuse histories. Chronic pelvic pain disorders are highly prevalent in the U.S., affecting between 10-21% of premenopausal women at some time in their lives. Chronic pelvic pain is associated with dyspareunia, depression, anxiety, relationship distress, functional impairment and poor quality of life. History of sexual abuse is associated with development of chronic pelvic pain and with the severity of psychological distress and functional impairment among chronic pain patients.

Unfortunately, frontline chronic pelvic pain treatments such as physical therapy and pain-specific psychological interventions fail to address sexual trauma. Standard physical therapy may actually trigger trauma related symptoms because it involves invasive techniques including internal digital palpation of pelvic floor muscles and the use of vaginal dilators. Neglecting trauma in chronic pelvic pain treatment could contribute to poor treatment outcomes, low adherence, and drop out. RESPECT's trauma-sensitive psychological intervention will teach women skills to cope with PTS, pain, sexual dysfunction, and discomfort during physical therapy. RESPECT's trauma-sensitive physical therapy intervention will more sensitively apply the invasive aspects of treatment and reinforce women's use of trauma-related coping skills learned in the psychological intervention. RESPECT is predicted to decrease chronic pelvic pain, PTS, dysfunctional sexual behavior, treatment avoidance.

Study Aims

  1. Develop a multi-level trauma-sensitive (psychological and physical therapy) chronic pelvic pain intervention for inner-city women with histories of sexual abuse and PTS symptoms.
  2. Examine the feasibility of RESPECT in treating this population.
  3. Use a pilot open trial to examine the impact of RESPECT chronic pelvic pain, PTS, dysfunctional sexual behavior, treatment avoidance.

RESPECT's trauma-sensitive psychological intervention will 1) educate the patient about the relations between sexual abuse, PTS, and chronic pelvic pain 2) empower her by explaining that sexual abuse, chronic pelvic pain, and PTS are not her fault but she has the power to combat them 3) desensitize her to anxiety provoking components of the physical therapy intervention, and 4) teach her relaxation tools that she can use during physical therapy sessions, while practicing at-home physical therapy exercises, and to cope with pain more generally.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Fluent in English
  • History of sexual abuse
  • Premenopausal
  • Chronic pelvic pain defined as pelvic pain with a duration of six months of at least a moderate severity

排除标准

  • Not menstruating for reasons other than birth control
  • Not currently receiving any current trauma-focused psychological treatment (i.e., prolonged exposure therapy, cognitive processing therapy, eye movement desensitization reprocessing)
  • No current psychotic symptoms or current use of anti-psychotic medications
  • No current suicidal ideation in the past month
  • Not currently pregnant

结局指标

主要结局

Chronic pelvic pain

时间窗: 4 months

Women will be asked to rate the severity of their pain during a variety of activities (e.g., pain at ovulation, pain while lifting) on a 10-point scale (0 = no pain, 10 = worst pain imaginable). Difference measured from pre to post intervention

Treatment avoidance

时间窗: 4 months

Women's pelvic floor functioning will be assessed by collecting data from patient's medical records which is typically recorded as part of routine clinical practice. Difference measured from pre to post intervention

Sexual History FOrm

时间窗: 4 months

The SHF will be used to assess participants' sexual history. The Female Sexual Function Index will assess participant's sexual feelings and responses. Women are asked 37 questions. Difference measured from pre to post intervention

Posttraumatic stress (PTS) - The 20-item PTSD Checklist for DSM-5 will be used to assess symptoms of Posttraumatic Stress Disorder. Items are rated on a 5-point Likert (scale with greater scores indicating more severe symptomatology

时间窗: 4 months

Difference from pre to post intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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